Cannabis Tolerance Break Resource Study: T-Break Guide

Cannabis Use Clinical Trial

Official title:

Cannabis Tolerance Break Resource Study: T-Break Guide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05382273
• Other study ID #: STUDY00001489
• Secondary ID: 03420-08153
• Status: Completed
• Start date: April 22, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: May 2022
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this pilot study is to conduct research into the value of using the T-Break Guide for assisting people taking a tolerance break from cannabis. The hope is that this initial research will yield some insights and benchmarks into the Guide's efficacy, and provide a foundation for a later randomized control study.

The following are some key research questions:

1. How did participants use the Guide? (Eg: daily; read once; 'a la carte')

2. How did using the Guide increase fidelity to tolerance break (starting, continuing, completing a break)?

3. Did using the Guide yield any benefits beyond tolerance break fidelity? (Eg: insight into patterns of use)

Description:

The pilot study used a pretest-posttest design in which participants completed a baseline survey and were asked to attempt a 21-day period of cannabis abstinence, to consider using the T-Break Guide (intervention) in their attempt, and to complete a follow-up survey after 30 days.

Participants were young adults aged 18-29 recruited through posters and tabling events at the University of Vermont (UVM), a post on a UVM webpage, emails on listservs of seven other universities, and a post on a subreddit focusing on responsible cannabis use. The posters and online announcements directed participants to the online baseline survey, which contained consent information before allowing participants to complete.

After completing the baseline survey, participants received a link to an online version of the T-Break Guide through email. After 30 days, participants received another email prompting them to complete the follow-up survey. The UVM Institutional Review Board reviewed and approved all study procedures (STUDY00001489).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: August 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Current cannabis partakers, willing to attempt at 21 day tolerance break (ie, period of cannabis abstinence)

Exclusion Criteria:

• No cannabis use in past month

Related Conditions & MeSH terms

• Cannabis Use
• Cannabis Withdrawal
• Marijuana Abuse
• Tolerance

Intervention

Behavioral:
• T-Break Guide
The T-Break Guide was designed to help people complete a 21-day break from cannabis. For each day of the break, the Guide offers inspiration in the form of a quote, reflections based on likely experiences occurring at that point during the break, advice on ways to overcome challenges, alternative activities in which to engage, and encouragement. The first week focuses on physical symptoms of cannabis withdrawal (e.g., sleep, appetite). The second week focuses on the emotional experience (e.g., anxiety, boredom). The third week focuses on behavioral aspects (e.g., examining patterns, connections). The T-Break Guide follows the Motivational Interviewing principles of affirmation and autonomy.

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont

Sponsors (3)

Lead Sponsor	Collaborator
University of Vermont	Dartmouth College, Rutgers University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Enkema MC, Hallgren KA, Bowen S, Lee CM, Larimer ME. Craving management: Exploring factors that influence momentary craving-related risk of cannabis use among young adults. Addict Behav. 2021 Apr;115:106750. doi: 10.1016/j.addbeh.2020.106750. Epub 2020 Dec 3. — View Citation

Enkema MC, Hallgren KA, Larimer ME. Craving is impermanent and it matters: Investigating craving and cannabis use among young adults with problematic use interested in reducing use. Drug Alcohol Depend. 2020 May 1;210:107957. doi: 10.1016/j.drugalcdep.2020.107957. Epub 2020 Mar 14. — View Citation

Schuster RM, Gilman J, Schoenfeld D, Evenden J, Hareli M, Ulysse C, Nip E, Hanly A, Zhang H, Evins AE. One Month of Cannabis Abstinence in Adolescents and Young Adults Is Associated With Improved Memory. J Clin Psychiatry. 2018 Oct 30;79(6). pii: 17m11977. doi: 10.4088/JCP.17m11977. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance Break Completion	Did the participant go 21 days without using cannabis? Self-report, "yes/no" question on followup survey	21 days
Secondary	Cannabis Use After 21 Days	How much cannabis are participants using after 21 days break? Followup survey question, 5 point Likert scale with "way more; a little more; same; a little less; way less" as response options	21 days
Secondary	Confidence in Future Break	Participants' confidence level about how successful they would be taking a future break	30 days
Secondary	Important of Balance	Participants' importance with finding/keeping balance in cannabis use going forward	30 days
Secondary	Alcohol and Other Drug Use During Break	What happened to participants' alcohol and other drug use while stopping cannabis? Self report by category of substance, asking use prior and change (if any) during break	30 days
Secondary	Future Cannabis Use	After taking a break, where do participants' picture their cannabis use in 3 years? Followup survey question, "Where do you picture your cannabis use 3 years from now" {"a lot more; a little more; about the same; a little less; a lot less; none}	30 days